BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOXPRESS GRAFT DELIVERY DEVICE

    MDR report key: 21849623 · Received April 16, 2025

    Report

    Report Number
    2183425-2025-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    December 30, 2021
    Report Date
    April 16, 2025
    Manufacturer
    MICROMEDICS, INC.
    Product Code
    FMF
    PMA / PMN Number
    K151543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MICROMEDICS BECAME AWARE OF THIS ADVERSE EVENT THROUGH OUR DISTRIBUTOR, (B)(4), ON (B)(6) 2025. THIS EVENT WAS REPORTED TO THE FDA BY (B)(4) IN (B)(6) 2022, WITHOUT INFORMING MICROMEDICS ABOUT THE ORIGINAL COMPLAINT. REGARDING PATIENT INFORMATION AND PREEXISTING MEDICAL CONDITIONS, NOTHING FURTHER HAS BEEN DISCLOSED TO MICROMEDICS. DURING THE INVESTIGATION OF THIS ADVERSE EVENT, WE CONSIDERED THREE PROBABLE ROOT CAUSES: A PROCESS ISSUE, A DESIGN ISSUE, OR USER ERROR. BASED ON OUR ANALYSIS, USER ERROR WAS DEEMED THE MOST LIKELY CAUSE. WHEN THE DEVICE IS USED AS INTENDED, THE STYLET STOPPER IS UNLIKELY TO DETACH AND FALL INTO THE PATIENT DUE TO EFFECTIVE DESIGN AND PROCESS CONTROLS. THE INSTRUCTIONS FOR USE (IFU) AND TYVEK LID PROVIDE GUIDANCE ON ASSEMBLING ALL COMPONENTS, USING BOTH TEXT AND ILLUSTRATIONS. OUR INTERNAL REVIEW OF THE FAILURE MODE INDICATED THAT USER ERROR WAS LIKELY RESPONSIBLE FOR THE INCIDENT. ONE POSSIBLE USER ERROR THAT COULD LEAD TO THE STOPPER DETACHING IS THE FAILURE TO USE ALL COMPONENTS. IF THE USER DOES NOT USE THE CANNULA DURING THE DEVICE'S OPERATION, THE STYLET STOPPER MAY HAVE A HIGHER CHANCE OF FALLING INTO THE PATIENT, AS THE CANNULA WOULD NOT PROVIDE A BARRIER. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, AND SINCE WE CANNOT CONFIRM WHETHER IT WAS USED AS INTENDED, MICROMEDICS HAVE CONCLUDED THAT USER ERROR IS THE MOST PROBABLE CAUSE. MICROMEDICS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE DEVICE CONTINUES TO PERFORM AS EXPECTED.

    Description of Event or Problem · 0

    MICROMEDICS BECAME AWARE OF THIS ADVERSE EVENT THROUGH OUR DISTRIBUTOR, (B)(4), ON (B)(6) 2025. THE INCIDENT HAPPENED ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE TO (B)(4) THAT AN ABS-10053-10 BIOXPRESS GRAFT DELIVERY, BLACK RUBBER TIP, FELL OF DEVICE INTO THE PATIENT. SURGEON INSERTED A SCOPE AND WAS ABLE TO LOCATE THE BLACK TIP AND RETRIEVE IT. THIS WAS DISCOVERED DURING A SUBTALAR FUSION PROCEDURE ON (B)(6) 2021. CASE WAS COMPLETED SUCCESSFULLY WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111430 BIOXPRESS GRAFT DELIVERY DEVICE SYRINGE, PISTON FMF MICROMEDICS, INC. ABS-10053-10 322965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention